Table Of ContentMEDICAL PROOFS, SOCIAL EXPERIMENTS
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Medical Proofs,
Social Experiments
Clinical Trials in Shifting Contexts
Edited by
CATHERINE WILL
University of Sussex, UK
TIAGO MOREIRA
Durham University, UK
First published 2010 by Ashgate Publishing
Published 2016 by Routledge
2 Park Square, Milton Park, Abingdon, Oxon OX14 4RN
711 Third Avenue, New York, NY 10017, USA
Routledge is an imprint of the Taylor & Francis Group, an informa business
Copyright © Catherine Will and Tiago Moreira 2010
Catherine Will and Tiago Moreira have asserted their right under the Copyright, Designs
and Patents Act, 1988, to be identified as the editors of this work.
All rights reserved. No part of this book may be reprinted or reproduced or utilised in any
form or by any electronic, mechanical, or other means, now known or hereafter invented,
including photocopying and recording, or in any information storage or retrieval system,
without permission in writing from the publishers.
Notice:
Product or corporate names may be trademarks or registered trademarks, and are used
only for identification and explanation without intent to infringe.
British Library Cataloguing in Publication Data
Medical proofs, social experiments : clinical trials in
shifting contexts.
1.Clinical trials--Social aspects.
I. Will, Catherine. II. Moreira, Tiago.
615.5'0724-dc22
Library of Congress Cataloging-in-Publication Data
Medical proofs, social experiments : clinical trials in shifting contexts / [edited] by Catherine
Will and Tiago Moreira.
p.cm.
Includes bibliographical references and index.
ISBN 978-0-7546-7928-8 (hardback) -- ISBN 978-0-7546-9832-6 (ebook)
1. Clinical trials. 2. Drug approval. I. Will, Catherine. II. Moreira, Tiago.
[DNLM: 1. Clinical Trials as Topic. 2. Drug Approval--methods. QV 771]
R853.C55M42 2010
615.5072'4--dc22
2010030306
ISBN 9780754679288 (hbk)
ISBN 9781315594675 (ebk)
Contents
List of Contributors vii
Introduction: Medical Proofs, Social Experiments: Clinical Trials in
Shifting Contexts 1
Catherine Will and Tiago Moreira
PART I: THE PRACTICES OF RESEARCH
1 Reconciling Research with Medical Care in RCTs 17
Stefan Timmermans
2 Bridging the Ontological Divide: Different Social Worlds in the
Conduct of a Pilot Study 33
Ben Heaven
3 From Dirty Data to Credible Scientific Evidence: Some Practices
Used to Clean Data in Large Randomised Clinical Trials 49
Claes-Fredrik Helgesson
PART II: FRAMING COLLECTIVE INTERPRETATION
4 Addressing the Commercial Context: The Collective Critique of Clinical
Trials 67
Catherine Will
5 When are Trials Not Enough? Clinical Versus Cost-effectiveness
in the Controversy Over Access to Dementia Drugs in the NHS 85
Tiago Moreira
vi Medical Proofs, Social Experiments
PART III TESTING THE LIMITS FOR POLICY
6 Comparing Artificial Groups: On the History and Assumptions
of the Randomised Controlled Trial 103
Trudy Dehue
7 Pragmatic Fact-making: Contracts and Contexts in the UK and the
Gambia 121
Ann Kelly
8 Trial, Trial, Trial Again: Reconstructing the Gold Standard in the
Science of Prostate Cancer Detection 137
Alex Faulkner
Conclusion: So What? 153
Tiago Moreira and Catherine Will
Bibliography 161
Index 183
List of Contributors
Trudy Dehue: Department of Psychology esp. Principles and History, University
of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, The Netherlands. Email:
[email protected].
Alex Faulkner: Centre for Biomedicine & Society, School of Social Science
& Public Policy, King’s College London, Strand Building (6th Floor), Strand,
London, WC2R 2LS. Email: [email protected].
Ben Heaven: Institute of Health & Society, Newcastle University, Medical
Sciences New Build, Richardson Road, Newcastle upon Tyne, NE2 4AX. Email:
[email protected].
Claes-Fredrik Helgesson: Department of Thematic Studies – Technology and
Social Change, Linköping University, SE-581 83 Linköping, Sweden. Email clae-
[email protected].
Ann Kelly: Anthropologies of African Biosciences Research Group, Health Policy
Unit, London School of Hygiene and Tropical Medicine, 15–17 Tavistock Place,
London, WC1H 9SH. Email: [email protected].
Tiago Moreira: School of Applied Social Sciences, Durham University, 32 Old
Elvet, Durham, DH1 3HN. Email: [email protected].
Stefan Timmermans: UCLA Department of Sociology, 266 Haines Hall, Los
Angeles, CA90095-155, United States. Email: [email protected].
Catherine Will: Department of Sociology, University of Sussex, Friston Building,
Falmer, Brighton, BN1 9SP. Email: [email protected].
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Introduction
Medical Proofs, Social Experiments:
Clinical Trials in Shifting Contexts
Catherine Will and Tiago Moreira
What kinds of ‘work’ must be done, and in what locations, to make credible
medical proofs? Who and what is involved in the production and articulation of
evidence to inform decisions about the organisation and distribution of healthcare
in contemporary societies? In this collection we explore the importance and
continued evolution of the controlled clinical trial as a key technique for producing
evidence in medicine, and for mediating between pharmaceutical companies,
clinicians, governments and the public.
In the first half of the 20th century a number of different methodological
factors came together to inform new experimental approaches to estimating the
effects of treatments, through comparisons between different groups of patients.
The use of randomisation to create these comparison groups, and the emphasis
on further techniques such as blinding to manage clinical optimism, became
increasingly important as trial methodology became standardised as part of efforts
to manage the claims made by the pharmaceutical industry (Marks, 1997). Since
the institutionalisation, in the 1960s, of the requirement to demonstrate clinical
efficacy as well as safety in order to obtain therapeutic marketing licences in
the United States and Europe, randomised controlled trials (RCTs) have been an
integral part of drug research and development. Indeed the organisation of trials is
now a sizeable industry in its own right, consuming many billions of dollars from
global pharmaceutical spending on research and development every year.1
Increasingly such trials have not only been used to adjudicate on safety or
efficacy, but also to help understand the everyday value of treatments and set
priorities for spending across health care organisations. In this context, there
has been an increase in trials designed to assess ‘effectiveness’, defined as the
benefit of an intervention under usual conditions (rather than the ‘ideal’ conditions
produced in a highly controlled efficacy trial). Meanwhile governments have
supported a wide range of trials directly, filling in the gaps left by commercial
R&D. In the UK since the 1990s these aims have been furthered by the Health
1 Global pharmaceutical spending was approximately $55 billion in 2000, 40% of
which was dedicated to clinical trials of new drugs (http./ec.europa.eu/internal_market/
indprop/docs/invent/patentingdna_en.pdf).
